CTRI/2024/06/068916尚未招募Unknown
Efficacy and compliance FDC Trisopt ophthalmic suspension versus individual eye drops in ocular hypertensive or glaucomatous patients.
Investigator initiated study1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年6月17日最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in IOP from baseline (Day 1) to Week 12.
研究概览
简要总结
To demonstrate the non-inferiority of Trisopt ophthalmic suspension (Single Vial fixed dose combination of Brinzolamide 1%, Brimonidine 0.2 % & Timolol 0.5%) compared with three individual eye drops of Brinzolamide 1%, Brimonidine 0.2 % & Timolol 0.5% in terms of efficacy and compliance.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or non-pregnant female aged 18 years or older with chronic open angle glaucoma or ocular hypertension in both eyes.
- •Provide signed and dated informed consent in accordance with good clinical practice (GCP) and local legislation prior to any study procedure.
- •Be able and willing to follow study instructions and complete all required visits.
- •Subject requires treatment of both eyes and is able to discontinue use of all ocular hypotensive medication(s) or switch ocular hypotensive medications and undergo appropriate washout period.
- •Baseline (Day 0/hour 0) IOP ≥ 22 mm Hg and ≤ 34 mm Hg in each eye and any asymmetry of IOP between the eyes no greater than 5 mm Hg.
- •Have a best spectacle-corrected visual acuity (BSCVA) equivalent to 20/200 or better in each eye.
- •Adequate wash-out period prior to baseline of any ocular hypotensive medication.
排除标准
- •Subjects with angle closure glaucoma
- •Females who are pregnant, breast feeding, or planning a pregnancy.
- •Females of childbearing potential who do not agree to utilize an adequate form of contraception.
- •Current, or history within 2 months prior to baseline of, significant ocular disease, e.g., corneal edema, uveitis, ocular infection, or ocular trauma in either eye.
- •Current corneal abnormalities that would prevent accurate IOP readings with the Goldmann applanation tonometer.
- •Functionally significant visual field loss.
结局指标
主要结局
Change in IOP from baseline (Day 1) to Week 12.
时间窗: Change in IOP from baseline (Day 1) to Week 12.
次要结局
- Drug Compliance by MARS-5(Week 6 and Week 12)
研究者
Prof Dr Lional Raj D
Dr. Agarwals Eye Hospital
研究点 (1)
Loading locations...
相似试验
已完成
4 期
A Randomised Control Study To Compare The Efficacy Of Intravitreal Faricimab6.0 mg Versus Aflibercept 2.0 mg In Management of Treatment Naive Diabetic Macular Edema In Indian PopulationCTRI/2024/09/073550Army Hospital Research And Referral72
尚未招募
4 期
Better corneal endothelium cell protection during cataract surgery in Type 2 Diabetes Mellitus patients using different Ophthalmic viscosurgical devicesCTRI/2025/09/094198Sankara eye hospital Guntur80
已完成
Unknown
A post market clinical study to assess the safety and performance of the eye drops/spray for treating eye redness and eye irritation in pediatric populationCTRI/2025/02/080344NOVAX PHARMA S.A.M.20
已完成
Unknown
A post-market clinical study to assess the safety and performance of eye drops/spray for treating eye dryness in pediatric populations.CTRI/2025/02/079918NOVAX PHARMA S.A.M.10
尚未招募
2 期
Safety and Efficacy of ophthalmic suspension (T1695 versus Ciclosporin), in participants with moderate to severe Vernal Keratoconjunctivitis (VKC).CTRI/2026/02/0104277Laboratoires THEA120